Tokyo, Oct. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059303) titled 'Effects of test food consumption on subjective fatigue in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study' on Oct. 6.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - ORIHIRO Plantdew Co., Ltd.

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effects of test food consumption on subjective fatigue in healthy Japanese. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Squalene capsule Interventions/Control_2 - Duration: 12 weeks Test product: Placebo capsule

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Adults

4. Healthy individuals

5. Individuals who experience temporary fatigue in daily life

6. Individuals who are judged by the physician to have no issues with study participation based on the results of the Beck Depression Inventory-Second Edition (BDI-II) at screening

7. Individuals with a large positive fatigue (VAS) value at screening, calculated as after workload minus before workload Key exclusion criteria - Individuals who

1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. have a pacemaker or an implantable cardioverter defibrillator

3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. are taking or using medicines (including herbal medicines) or supplements

6. are allergic to medicines or foods related to the test product (particularly fish or gelatin)

7. are pregnant, lactating, or planning to become pregnant during this study

8. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

9. have mental health issues such as depression disorder or attention deficit/hyperactivity disorder

10. are undergoing medical treatment or have a medical history of chronic fatigue syndrome

11. have irregular working patterns, including those involving night shifts

12. work in physical labor such as transportation of heavy objects

13. have irregular lifestyles (whose habits vary every day such as dietary habits, exercise habits, and sleeping habits)

14. consume alcohol in excess daily

15. consume foods containing ingredients that may affect fatigue or stress (e.g., S-allylcysteine, gamma-aminobutyric acid, lactic acid bacteria, reduced Coenzyme Q10, Euglena gracilis-derived paramylon, docosahexaenoic acid, eicosapentaenoic acid, astaxanthin, citric acid, L-Theanine, black soybean polyphenols, 5-aminolevulinic acid phosphate, anserine)

16. are judged as ineligible to participate in this study by the physician Target Size - 60

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 09 Month 10 Day Date of IRB - 2025 Year 09 Month 10 Day Anticipated trial start date - 2025 Year 10 Month 06 Day Last follow-up date - 2026 Year 04 Month 17 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067834

Disclaimer: Curated by HT Syndication.